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临床试验/CTRI/2022/04/041622
CTRI/2022/04/041622尚未招募3 期

Effect of add on dapagliflozin versus standard-of-care on bone and mineral indices in postmenopausal women with type2 diabetes mellitus: a randomized controlled study

Department of Endocrinology0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
尚未招募

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1.Post-menopausal women ( duration of menopause > 5years ) and age < 65 years diagnosed with T2DM and being initiated on SGLT2i shall be enrolled into the study.
  • 2.Patients on diet alone therapy or with other anti-diabetic agents (metformin, alpha-glucosidase inhibitors, DPP4i or insulin) may be used for achieving glycaemic targets.
  • 3. HbA1C <10 %
  • 4.Duration of DM > 5 years

排除标准

  • 1. Current users of any of the SGLT2i (Cana or Dapa or Empa )
  • 2.Patients on bone active agents (anti-resrorptives or osteoanabolics)
  • 3.Patients on chronic glucocorticoid therapy ( >3 months)
  • 4.Other drugs (thiazolidinediones, phenytoin, tamoxifen, estrogen, combined OCs)
  • 5.eGFR <30ml/min/m2
  • 6.Contraindication or hypersensitivity to SGLT2i
  • 7.Patients with T1DM, FCPD or known case of secondary diabetes
  • 8.Pregnant or lactating women
  • 9.Premature ovarian insufficiency
  • 10.HbA1C >10%
  • 11.Known case and/or specific features of Cushingââ?¬•s, Addisonââ?¬•s, acromegaly, prolactinoma, uncontrolled hypothyroidism, hyperthyroidism, celiac disease, primary hyperparathyroidism
  • 12.Those unwilling for consent to participate and follow-up

研究者

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